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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00279968
Other study ID # 231
Secondary ID
Status Completed
Phase N/A
First received January 19, 2006
Last updated December 26, 2007
Start date February 2004
Est. completion date January 2006

Study information

Verified date December 2007
Source Medtronic Cardiac Rhythm Disease Management
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.


Recruitment information / eligibility

Status Completed
Enrollment 1326
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients 18 years of age or older.

- Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent.

- New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD.

Exclusion Criteria:

- Patients enrolled in a device study which effects programming and or treatment.

Study Design

Time Perspective: Prospective


Intervention

Device:
ICD


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm Disease Management Medtronic

Country where clinical trial is conducted

United States, 

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